UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046135 |
|---|---|
| Receipt number | R000052592 |
| Scientific Title | Effects of milking mothers of newborns anticipated to feed poorly |
| Date of disclosure of the study information | 2021/11/22 |
| Last modified on | 2023/06/19 10:02:13 |
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Basic information
Public title
Effects of milking mothers of newborns anticipated to feed poorly
Acronym
Effects of milking mothers of newborns anticipated to feed poorly
Scientific Title
Effects of milking mothers of newborns anticipated to feed poorly
Scientific Title:Acronym
Effects of milking mothers of newborns anticipated to feed poorly
Region
| Japan |
Condition
Condition
Postpartum mother and new borns
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether milking mothers of new born in preterm or less than 30 percentile of mean gestational age weight,
promote breast feeding and the infants to breast feed at during the early postpartum period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Formula volume at 3th day of puerperium
Key secondary outcomes
Percentage of breast feeding, percentage of weight increase of the newnborns, and level of mother satisfaction with breast feeding at the 1 month medical check up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Milking within 2hours after birth, and 4 times per day till discharge
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Mothers and newborns born at Nagasaki University Hospital, admitting maternity ward from childbirth to discharge, preterm infants (36 weeks), low birth weight (less 30 percentile than gestational age), ability to understand Japanese.
Key exclusion criteria
Newborn with congenital complications affecting feeding (heart disease), malformations (such as cleft lip and palate).
Mothers wishing to control milk (because of HTLV-1 adult T-cell leukemia positive, etc.), and multiple births.
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Eto |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7922
heto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Yoshida |
Organization
Nagasaki University hospital
Division name
General Affairs Division
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7229
Homepage URL
y-yu0418@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinicalb Research Center
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7726
rinshou7726@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
104
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052592
